Quality Management in Pharmaceutical and Medical Device Companies in New Zealand involves ensuring that products meet regulatory standards and maintain consistent quality throughout their lifecycle. This includes implementing a robust Quality Management System (QMS) that aligns with global standards like ISO 13485 and ISO 9001

Standard Operating Procedures (SOPs) are essential for maintaining consistency and quality. SOPs provide detailed, written instructions for specific tasks, ensuring that all activities are performed correctly and consistently. They are living documents that need regular review and updates to reflect best practices and regulatory changes

Audits for post-market vigilance Practice in New Zealand are essential to ensure the safety and efficacy of therapeutic products. The audits assess various aspects, including the reporting of adverse reactions, signal detection and management, and compliance with regulatory requirements. They help identify potential risks and ensure that appropriate measures are in place to protect public health.